The Pharma Data

JULY 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994, 1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors. – If Approved, Investigational TAK-994 May Provide a Future Treatment Option Targeting the Orexin Deficiency Underlying NT1.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 /PRNewswire/ — Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing. CARLSBAD, Calif. ,

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Drug Target Review

JULY 17, 2024

How does GigaGen’s single-cell discovery and development platform differ from traditional methods of producing polyclonal antibody therapies? Current methods for producing pAb therapies rely on regular plasma donations for their development.

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The Pharma Data

APRIL 8, 2021

Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. In the U.S.

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Conversations in Drug Development Trends

MAY 1, 2024

By: Sarah Bly and Aman Khera, Regulatory Science and Innovation The journey of bringing a new therapeutic agent from the laboratory to the marketplace is fraught with challenges, not least of which is navigating the complexities of regulatory feedback, which do not always converge but can diverge.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Why Partnering with Genetic Counselors May Benefit Your Clinical Program The American College of Medical Genetics (ACMG) has issued a statement that geneticists should be involved in the development of genetic therapies. Enrolling adequate populations will be required to advance these programs.

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The Pharma Data

DECEMBER 9, 2020

The Chinese biopharmaceutical industry is growing in leaps and bounds, but there is still a huge unmet need when it comes to getting patients access to the breakthrough therapeutic modalities and platforms like RNAi, cell and gene therapy and others. Additionally, the capital will be used to further expand the existing laboratory capacities.

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Drug Target Review

APRIL 9, 2024

Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy. These compounds were later licensed to the pharmaceutical industry for clinical development.

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The Pharma Data

JANUARY 21, 2021

Precigen is focused on next-generation gene and cell therapy using precision technology. The compound was developed in the laboratory of Richard Childs, chief of the Laboratory of Transplantation Immunotherapy with the National Heart, Lung, and Blood Institute (NHLBI). Precigen – Germantown, Md.-based It filed for a U.S.

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The Pharma Data

NOVEMBER 9, 2020

These data also support the potential first-line use of LENVIMA plus everolimus, which is already approved in advanced RCC following prior antiangiogenic therapy,” said Dr. Takashi Owa, Vice President, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. Source link.

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Drug Target Review

NOVEMBER 30, 2023

On my return to Europe, I took a position at Nestlé as Head of the Research Centre, where I led the scientific development of several highly innovative health promoting food products from laboratory to market. We – as a team – are very proud to be advancing these products, three of which are in mid- to late-stage clinical development.

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The Pharma Data

AUGUST 31, 2021

today announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. Source link: [link].

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The Pharma Data

JUNE 25, 2021

Merck is continuing to study KEYTRUDA, in combination or as monotherapy, as well as other investigational products across multiple settings and stages of RCC including adjuvant and advanced or metastatic disease through our broad clinical development program, which includes over 20 clinical studies and more than 4,000 patients.

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The Pharma Data

APRIL 15, 2022

A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and Washington University at St. Louis is being advanced toward Phase I human clinical trials to treat COVID-19. Hunt, a graduate research fellow in Jewett’s laboratory, is the paper’s co-first author.

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The Pharma Data

MARCH 15, 2022

The safety profile of KEYTRUDA in combination with LYNPARZA in this trial was consistent with that observed in previously reported studies for the individual therapies; however, the combination was associated with a higher incidence of grade 3-5 adverse events and drug-related serious adverse events, compared to the control arm.

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The Pharma Data

JUNE 30, 2021

Event-free survival is defined as time from randomization to disease progression, commencement of new lymphoma therapy, or death from any cause. Food and Drug Administration (FDA) whereby the trial design, clinical endpoints and statistical analysis were agreed in advance with the Agency. “The View the full release here: [link].

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The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group.

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The Pharma Data

AUGUST 7, 2020

As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. Regenerative medicine and advanced therapies thriving despite Covid-19 disruption.

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The Pharma Data

JANUARY 19, 2021

The company hopes to raise $140 million of common stock, which will be used to advance its clinical and earlier stage programs and for R&D, working capital and general corporate purposes. TCR 2 is developing novel T-cell therapies for solid tumors and hematological cancers. The company is based in Suzhou and Shanghai, China.

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Drug Target Review

OCTOBER 10, 2024

What are the risks of over-reliance on healthy donor material in early-stage research, and how can decision-makers ensure a balanced integration of diseased material to avoid potential gaps when transitioning to clinical trials? Diseased cells are likely to be more fragile or less abundant, making it difficult to obtain enough for therapy.

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Vial

MARCH 1, 2024

billion in 2023 attributable to its laboratory products and biopharma services segment (53.8% By type of service, clinical research services accounted for the lion’s share of the North American CRO services market, followed by early-phase development services, laboratory services, and consulting services.

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The Pharma Data

JUNE 2, 2023

Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. prostate cancer is the second most common cancer in men, and despite an increase in the number of available therapies for patients with mCRPC, five-year survival remains low. 0.45]) and overall survival (OS) (HR=0.30 [95% CI, 0.15-0.59])

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The Pharma Data

OCTOBER 1, 2021

Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies. Data on the efficacy of deucravacitinib, no matter prior psoriasis treatment (Presentation FC03.06), were featured as an public speaking today from 2:30 – 3:30 p.m.

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The Pharma Data

SEPTEMBER 28, 2021

Triple-negative carcinoma grows and spreads faster than other sorts of carcinoma and consequently features a worse prognosis,” said Dr. Vicki Goodman, vice chairman , clinical research, Merck Research Laboratories. Importantly, this treatment regimen are often utilized in combination with different chemotherapy agents.

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The Pharma Data

JUNE 7, 2023

Consider the potential for drug interactions prior to and during PREVYMIS therapy; review concomitant medications during PREVYMIS therapy; and monitor for adverse reactions associated with PREVYMIS and concomitant medications. See additional Selected Safety Information below. Source link: [link]

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The Pharma Data

JANUARY 21, 2021

Prior to joining Labcorp, she held multiple appointments with The Children’s Hospital of Philadelphia, including Patient Safety Officer, chief of the Division of Transfusion Medicine and Vice-Chief of Pathology and Laboratory Medicine. Abbott Laboratories and TAP Pharmaceuticals. a company previously known as miRagen Therapeutics.

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The Pharma Data

AUGUST 10, 2021

The FDA’s acceptance of our application adds to our momentum of advancing new treatment options to address the most challenging cancers facing women,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. About KEYTRUDA ® (pembrolizumab) Injection, 100 mg.

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The Pharma Data

NOVEMBER 8, 2020

HK) (“Pharmaron”), a fully integrated contract research and manufacturing organization offering laboratory, CMC and clinical development services for the life science industry, announced today that it has acquired 100% of the equity of Absorption Systems for up to US$137.5 Limited (Stock Code: 300759.SZ/3759.HK) million in cash.

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The Pharma Data

JULY 15, 2021

The trial investigated neoadjuvant KEYTRUDA, Merck’s anti-PD-1 therapy, plus chemotherapy followed by adjuvant KEYTRUDA as monotherapy (the KEYTRUDA regimen) compared with neoadjuvant chemotherapy followed by adjuvant placebo (the chemotherapy-placebo regimen) in patients with high-risk early-stage triple-negative breast cancer (TNBC).

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The Pharma Data

MARCH 16, 2021

While peripherally acting COMT inhibitors are currently used as an adjunctive therapy in the treatment of neurological conditions, including Parkinson’s disease, this new collaboration is investigating centrally acting COMT inhibitors in neuropsychiatric disorders. “We Our mission is to create breakthrough therapies that change lives.

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The Pharma Data

MARCH 5, 2021

Currently available BTK inhibitors irreversibly inhibit BTK and the long-term efficacy of these therapies can be limited by acquired resistance, most commonly through BTK C481 mutations. In rapidly growing tumors with inherently high rates of BTK turnover, resistance to covalent BTK therapies may be the result of incomplete target inhibition.

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The Pharma Data

JANUARY 13, 2021

Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinical development, such as priority review and accelerated approval. Brilacidin antiviral research to date has been limited to laboratory-based experiments.

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The Pharma Data

JANUARY 20, 2021

Dr. John Teerlink – Professor of Medicine, University of California, San Francisco and Director of Heart Failure and the Echocardiographic Laboratory at the San Francisco Veterans Affairs Center. Wells is the author or co-author of over 400 published articles. About Cardiol Therapeutics. Cardiol Therapeutics Inc. (

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PPD

NOVEMBER 14, 2023

In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development. Here’s how we do it. Recruitment and talent management are critical to FSP performance.

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The Pharma Data

JUNE 26, 2021

Libtayo is the first immunotherapy to show a clinical benefit in patients with advanced BCC after HHI therapy in a pivotal trial, and with this first-in-class approval has the potential to transform treatment for patients in Europe whose cancer has progressed despite HHI treatment ,” said Israel Lowy, M.D.,

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The Pharma Data

NOVEMBER 22, 2020

The drug is a once-daily oral precision therapy designed for highly potent and selective targeting of oncogenic RET alterations. In addition to RET-altered NSCLC, it is being developed for RET-altered thyroid cancer and other solid tumors. The FDA approved it under the brand name Gavreto on September 4.

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The Pharma Data

JANUARY 24, 2021

In a series of laboratory experiments, StemVacs administration was demonstrated to induce regression of GL261 glioma, CT-26 colorectal cancer, and Lewis Lung Carcinoma tumors grown in mice. OCEANSIDE, Calif., 25, 2021 /PRNewswire/ — Therapeutic Solutions International, Inc., (OTC ir@tsoimail.com.

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